EBI SPINELINK SYSTEM— 510(k) K971970

Substantially Equivalent

Electro-Biology, Inc.

FDA 510(k) clearance K971970 for EBI SPINELINK SYSTEM, Substantially Equivalent on 1997-08-20. Applicant: Electro-Biology, Inc..

Clearance details

Applicant: Electro-Biology, Inc.
Product code: Code MNH
Advisory panel: Orthopedic
Date received: 1997-05-29
Decision date: 1997-08-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Parsippany, NJ, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MNH

product code MNH

Injury: 978
Malfunction: 793
Total: 1,771

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.